Second-generation Radiofrequency Application and Therapeutic Exercise for Stress Urinary Incontinence

Recruiting

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT07095283
• Lead Sponsor: Cardenal Herrera University

Brief Summary

Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI).

The objective of the present study is to analyse the effectiveness of EMSP and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or EMSP. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment.

The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience.

The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Study First Posted: 2025-07-31
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-13
• Primary Completion: 2025-08-20
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women over the age of 18 who meet the International Continence Society (ICS)
• diagnostic criteria for SUI, which consists of involuntary leakage of urine during increased intra-abdominal pressure in the absence of bladder contractions such as coughing, sneezing, and other physical activities.

Exclusion Criteria

• diagnosis of urgent or mixed UI
• diagnosis of pelvic organ prolapse
• taking any treatment for UI
• pregnancy
• history of pelvic surgery, urinary tract infection, or diagnosed psychological disorders
• presence of scars, malformations, abnormal pelvic masses, tissue irritation, or any other condition in the area that could be causing pelvic and urinary function problems

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire (ICIQ-SF)	baseline	0 to 21 points, where higher scores indicate greater impact of incontinence
King´s Health Questionnaire (KHQ)	baseline	0 to 100, where 0 indicates the best quality of life and 100 the worst
ultrasound analysis: Resting aperture (Ar)	baseline	degrees
ultrasound analysis: Opening during exertion (Ae)	baseline	degrees
Opening difference (Ae-Ar)	baseline	degrees

Secondary Outcome Measures

Name	Time	Method
age (years)	baseline
BMI (Body mass index)	baseline	kg / m²
smoke	baseline	yes/no
alcohol consumption	baseline	yes/no
drug use	baseline	yes/no
full-term pregnancies	baseline	Number
natural childbirth	baseline	yes/no
cesarean sections	baseline	yes/no
tear	baseline	yes/no
abortion	baseline	yes/no
episiotomy	baseline	yes/no

Trial Locations

Locations (1)

Ceu Cardenal Herrera University; 🇪🇸 Elche, Alicante, Spain